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Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)

Primary Purpose

Eating Disorder, Emotional Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Integrative cognitive-affective therapy for adolescents (ICAT-A)

About this trial

This is an interventional treatment trial for Eating Disorder

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
No major weight loss (defined as a reduction of 10% baseline body weight or more)
Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
Subject must be living at home
At least one parent/guardian is willing to participate in the treatment.

Exclusion Criteria:

Subject on medications that influence weight or appetite (including antipsychotic medications)
Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adolescents with Eating Disorder

Arm Description

Adolescents with bulimia nervosa or binge eating disorder, with one or more of their parents, will receive integrative cognitive-affective therapy for adolescents (ICAT-A).

Outcomes

Primary Outcome Measures

Change in Eating Disorder Examination (EDE)

The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales and a global score. The four subscales are: 1) Restraint, 2) Eating concern, 3) Shape concern, 4) Weight concern. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period, but some questions extend out to cover the previous 3 months. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall score, the four subscales scores are summed and the resulting total divided by the number of subscales (4). The total score can range from 0 (normal) to 6 (high eating disorder).

Secondary Outcome Measures

Full Information

NCT ID

NCT03324724

First Posted

September 5, 2017

Last Updated

June 3, 2022

Sponsor

Mayo Clinic

Collaborators

National Eating Disorders Association

1. Study Identification

Unique Protocol Identification Number

NCT03324724

Brief Title

Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders

Acronym

ICAT-A

Official Title

Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

January 9, 2017 (Actual)

Primary Completion Date

October 2021 (Actual)

Study Completion Date

October 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Eating Disorders Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eating Disorder, Emotional Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adolescents with Eating Disorder

Arm Type

Experimental

Arm Description

Adolescents with bulimia nervosa or binge eating disorder, with one or more of their parents, will receive integrative cognitive-affective therapy for adolescents (ICAT-A).

Intervention Type

Behavioral

Intervention Name(s)

Integrative cognitive-affective therapy for adolescents (ICAT-A)

Intervention Description

Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions.

Primary Outcome Measure Information:

Title

Change in Eating Disorder Examination (EDE)

Description

Time Frame

baseline, end of treatment (approximately 8 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly) No major weight loss (defined as a reduction of 10% baseline body weight or more) Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks Subject must be living at home At least one parent/guardian is willing to participate in the treatment. Exclusion Criteria: Subject on medications that influence weight or appetite (including antipsychotic medications) Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months) Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jocelyn R Lebow, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders

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